Child, Only, Esophageal and Gastric Varices
Conditions
Brief summary
Prospective investigations into the role of hemostatic factors in the risk of variceal bleeding among children with chronic liver disease (thromboelastometry e.g) is still required. A better understanding of these factors would permit better risk stratification and targeted prophylaxis or therapy.
Detailed description
The investigators aim to start a prospective and observational study over a 2 years period. First, the investigators will identify all children suffering from cirrhosis irrespective of underlying etiology and/or portal hypertension coming into the pediatric hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or acquired thrombophilia/haemorrhagic disorder will be excluded. The investigators expect to include 20 to 30 children in the study. The investigators will meet the parents to give them explanations about this study and its implications. Then the investigators will get the free and informed consent about the participation to this clinical study. Parents are obviously free to refuse to take part in this clinical study and to retire from it at any moment.
Interventions
OTHERCollecting Clinical Data
Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)
OTHERCollecting laboratory data
Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The investigators aim to start a prospective and observational study over a 2 years period. First, the investigators will identify all children suffering from cirrhosis irrespective of underlying etiology and/or portal hypertension coming into the pediatric hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or acquired thrombophilia/haemorrhaegic disorder will be excluded.
Eligibility
Sex/Gender
ALL
Age
4 Months to 50 Years
Healthy volunteers
No
Inclusion criteria
* Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation * Children suffering from a compensated cirrhosis (compensated cirrhosis with kasai surgery in biliary atresia patients e.g) or from portal hypertension without cirrhosis (portal vein thrombosis e.g) * Each patient will have a comprehensive assessment of portal hypertension (abdominal US-Doppler and upper gastrointestinal endoscopy) and hemostasis
Exclusion criteria
* No underlying disease which can alter hemostasis (hemophilia, sepsis…) * No medication which can alter hemostasis (aspirin, anti-inflammatory drugs,…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions | over 2 year period |
Countries
Belgium
Outcome results
None listed